# ·**~ALBEMARLE®**

-Albemarle Corporation 451 Florida Street Telephone: 225-388-8011 Baton Rouge, Louisiana 70801-1765 Facsimile: 225-388-7686 

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May 30,2012 VIA OVERNIGHT MAIL Document Control Office (7407M) Office of Pollution Prevention and Toxics (OPPT) Environmental Protection Agency 1201 Constitution Ave_, N.W. Washington, DC 20004-3302 

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### Attn: TSCA Section 4 In compliance with the final rule, "Testing of Certain High Production Volume Chemicals; Second Group of Chemicals", 76FR1067, January 17, 2011, Albemarle Corporation submits this outline Study Plan for "Benzenediamine, ar,ar-diethyl-ar-methyl-", CAS number 68479-98-1. i) Identity of the test rule "Testing of Certain High Production Volume Chemicals; Second Group of Chemicals", 76FR1067, January 17, 2011 ii) Specific test requirements of the rule covered by the study plans. This study plan addresses the following end points: F1
- Developmental Toxicity Study iii) and A) The names and addresses ofthe test sponsors are provided below. Albemarle Corporation 451 Florida Street Baton Rouge, LA 70801-1765 Lonza Inc. 90 Boroline Road Allendale, NJ 07401 USA B) The name, address, and telephone numbers ofthe project manager in the sponsor organization. Sylvia Jacobi Albemarle Corporation Parc Scientifique Einstein Rue de Bosquet 9 B-1348 Louvain-Ia-Neuve, Belgium Tel: 3210481711 11111111111 1111111111111111111111111 11111111111111111111 11111111 401 200 000 7 2 

### Fax: 3210481717 Sylvia.Jacobi@albemarle.com C) The name, address, and telephone number ofthe appropriate individual to contact for oral and written communications with EPA is:

# CONTAINS NO CBI

### Kim Boudreaux Albemarle Corporation 

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# 1-' 451 Florida Street Baton Rouge, LA 70801-1765 Tel: 225-388-7776 Fax: 225-388-7046 Email: KimBoudreaux@albemarle.com D) 1) Name and address oftesting facility, administrative official, and project managers. TNO Triskelion Utrechtseweg 48, 3704 HE Zeist The Netherlands Tel: +31 888669284 The Study Director is J.G. theuns -van Vliet 2) The Curriculum Vitae for persons involved with the studies will be provided for the definitive study. ivThe identity ofthe test substance is "Benzenediamine, ar, ar-diethyl-ar-methyl" (CAS No. 68479-98-1). The same test article used for all other studies underthis test rule will be used for this study. The material is commercial DETDA with 97.27% purity v) A protocol for each proposed test is attached. F1
- Developmental Toxicity Study Please find attached an outline protocol for the dose range finding study for developmental affects. vi) This study is scheduled to begin on June 6,2012

.. Ifyou have any questions, please contact me and at the number provided above. Sincerely,

# ~~h~ Kim 

### A. Boudreaux Sr. Advisor, Regulatory Affairs
cc: Wayne Chu (via email)1/2 Outline Protocol Dose range finding study for developmental toxicity study in rats (OECD 414) Study number 20193DRF 

# -rNO triskelion bv

Dose range finding study for developmental toxicity study in rats
Guideline non GLP Objective Dose range finding study to select dose levels for the subsequent main oral developmental toxicity study toxicity study in the same species. Groups Group Number of mated females 6 

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### 6 One control group and three test groups administered different dose levels ofthe test substance; 6 mated females per group. Route ofadministration Oral via diet Housing Female rats will be housed individually during gestation in macrolon cages. Species Mated female Wistar rats (RccHanT!II: Wist, Harlan), The Netherlands; approximately 12 weeks ofage at start. Diet Commercial rodent diet (Rat & Mouse No.3 Breeding diet. RM3), adlibitum Treatment Daily administration ofthe test substance via diet during gestation from the start of gestation (day 1) until sacrifice (gestation day 21). Stability, homogeneity and content ofthe test substance in the carrier Analysis to demonstrate content ofthe test substance in the carrier will be performed. During the dose range finding study the method ofanalysis will be validated. Clinical observations General clinical observations: daily; morbidity is checked again in the afternoon (weekends and public holidays one check per day). Body weight Forfemales during gestation: gestation days 1,3,7, 10, 14, 17, and 21. Food consumption Forfemales during gestation: gestation days 1,3,7, 10, 14, 17, and 21. Ophthalmoscopsy Opthalmoscopy will be performed around day 2 ofgestation in all animals and prior to necropsy on gestation day 21. Special attention will be paid to cataract. Sacrifice and necropsy parameters On gestation day 21 the animals will be sacrificed and caesarean section will be performed. The following parameters will be examined: uterus weight, containing placentas and embryos number ofcorpora lutea number of implantation sites number ofearly and late resorptions number of live and dead fetuses number ofgrossly visible malformed fetuses and fetuses with external abnormalities ovary weight TNO Triskelion bv

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i Outline Protocol Dose range finding study for developmental toxicity study in rats (OECD 414) Study number: 20193DRF 

# -rNO triskelion bv gross evaluation ofthe placentas abnormal tissue or organs in dams histopathology will be performed on the pancreas ofthe dams 

### Clinical Chemistry At autopsy blood will be collected from all animals for determination oftransaminases and gamma-GT. 

### Haematology At autopsy blood will be collected from all animals for haematology determinations including platelet and lymphocyte count. 

### Fetal pathology Fetal pathology will not be performed in the dose range finding study. 

### Calculated parameters Post-implantation loss


### Time schedule: Start ofthe study (arrival ofthe animal): 8juni 2012 Sacrifice (all animals): 28 june 2012



### Authorization



### C8:J Study Director J.G. Theuns
- van Vliet Signature: Date:

........................ (dd-mm-yyyy) 

### C8:J Sponsor Name company: Albemarle Name contact person: S. Jacobi Signature:

Date:

........................ (dd-mm-yyyy)

TNO Triskelion bv

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